Events

Retiro De Equipo (Recall) de Biotronik Pulsar-35 Peripheral Stents, 200mm

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Biotronik AG.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    18564
  • Fecha de inicio del evento
    2015-05-22
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Biotronik Australia Pty Ltd (NZ), 44 Cornwall Park Ave, Epsom, Auckland 1051
  • Causa
    The manufacturer has received a higher than expected number of complaints regarding incomplete stent deployments with specific sizes and lots of our pulsar-18 and pulsar-35 peripheral self-expanding nitinol stent systems. potential health hazards resulting from this type of failure include increased procedure time, vessel wall injury or the need to remove the incompletely deployed stent.
  • Acción
    Product to be returned to supplier

Device

Biotronik Pulsar-35 Peripheral Stents, 200mm
  • Modelo / Serial
    Model: Product Codes: 379921, 379941, 379926, 379946, 379931, 379951, Affected: Selected lot numbers
  • Manufacturer
    Biotronik AG

Manufacturer

Biotronik AG
  • Empresa matriz del fabricante (2017)
    Ms Holding Ii Se
  • Comentario del fabricante
    Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.
  • Source
    NZMMDSA